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456, Road 3, Industrial Area,
Jigani, Bangalore South – 562106
Karnataka, India
NOTICE TO READER
The statements in this business plan represent the intentions, plans, expectations, and beliefs of the company Stellence Pharmscience Limited (SPL) and Avigna Chemitech Pvt Ltd (ACPL) and are subject to risks, uncertainties, and other factors, of which many are beyond the control of the Company. These factors could cause actual results to differ materially from such forward-looking statements. These factors include and are not restricted to: regulatory approvals; the timing and size of contracts, acquisitions and other corporate developments; the ability to attract and retain qualified employees; market competition in the generic pharmaceutical industry; general economic and business conditions, foreign exchange and other risks as well as assumptions regarding the foregoing.
No representation or warranty is made as to the accuracy or completeness of any part of the information
contained in this business plan or any other written or oral communication transmitted in the course of the evaluation of Stellence Pharmscience Limited or ACPL. The only legal obligations of the corporation will be those contained in a definitive written agreement.
This business plan and the information herein shall not be copied, reproduced or in any way distributed,
directly or indirectly, to others at any time except, if applicable, in accordance with the terms and subject to the conditions of a Confidentiality Agreement. Upon request, the recipient will promptly return to:
Stellence Pharmscience Limited,
456, Road #3, Industrial Area,
Jigani, Bangalore South 562 106.
To the attention of:
Managing Director.
COMPANY PROFILE
Established in the year 2005, Bangalore, Karnataka, India as a leading
company for the manufacturing of Niche Pharmaceutical products like contrast media agents.
Company is promoted by extensively experienced entrepreneurs of the pharmaceutical industry.
The company has cGMP certified state -of –the- art manufacturing facility.
Stellence Pharmscience Limited (SPL) is committed to develop a centre of excellence for NDDS (New Drug Delivery Systems).
SPL has established a DSIR (Department of Scientific and Industrial Research) recognized R&D facility.
SPL believes in nurturing and promoting talents and therefore and it has an excellent pool of scientists recruited from industry and academia.
CORE COMPETENCE
API Manufacturing Pharmaceutical formulations
Agrochemicals Bio -
pharmaceuticals
M i s s i o n S ta te m e nt : O u r B e l i e f a n d P r o m i s e
WE STRONGLY BELIEVE………
that, as a corporate entity in an industrial environment, our responsibilities extend way beyond day to day management of our company and its environs.
in unequivocal excellence spanning all functioning areas and across all levels of our Company with clearly measurable evidence of success.
in continuous innovation with a clear emphasis on Science and it will be our endeavor to perform even ordinary tasks extra ordinarily. We shall do so with complete honesty and integrity.
that, being a corporate entity, generation of profits is an integral and essential part of our sustenance and growth. We will achieve it, by ensuring that all our products (actions) reflect our intrinsic values while providing distinctive societal benefits.
V I S I O N 2 0 1 5 :
Stellence Pharmscience Limited to be amongst the top five manufacturers of non-ionic Contrast Media in the world.
Stellence Pharmscience Limited to be the best API and Contract Development and Manufacturing Company in Karnataka State, that has all equipments and systems in place. This will enable our Research teams to function in a manner conducive to providing full fledged support to Medicinal and related Chemistry activities of the company.
Stellence Pharmscience Limited to be the preferred choice Contract Manufacturer for intermediates for our partner companies.
Stellence Pharmscience Limited will have an enviable Team in place to achieve this vision.
Q UA L I T Y P O L I C Y
We shall develop and manage our business to ensure that all our activities are based on established processes and every product manufactured by us will more than meet the specified quality standards.
All our operations will be carried out by fully complying with all regulatory and statutory requirements, ethically and with complete integrity.
We shall always meet all our commitments and will constantly strive to enhance the satisfaction of all interested parties in the value chain.
O U R F O C U S
Partnership with global players in exciting chemistries
Contract Manufacturing - long term relationship based on integrity and
timely deliveries and respect for IPR's
Work with clients from the research stages, through process
development and commercialization
Continuous improvements in process efficiencies, product quality over
the life of project.
Sustainable products.
T H E D I F F E R E N T I ATO R S
All manufacturing facilities and controls are designed to comply with
global regulatory requirements – Systems oriented
Process Research Capabilities
cGMP Compliant Manufacturing Facility for APIs
Interesting and difficult chemistry/reactions capability in-house at
lab, pilot and plant level.
Quality, Consistency, Timely Delivery and Customer Delight!
R E A C T I O N C A PA B I L I T I E S
Hydrogenation
Friedel Crafts
Reaction
Alkylation
Chlorination
Nitration
Bromination
Grignard
Diazotization
Esterification
Vilsmeier Reaction
Oxidation
Reduction
Resolution
Asymmetric Synthesis
FAC I L I T I E S
Non GMP Intermediate/ Fine Chemicals Manufacturing :
Laboratory Capacities : Small Volumes 100 Gms to 5 Kgs
Fume Cupboards 6 nos
Vessel Capacities 50 ml to 20 lts
Nutsche Filters 50 Gms to 5 Kgs
Driers Fluid Bed and Vacuum Tray Driers
Hydrogenator 10 lts – 100 Kgs Pressure
FAC I L I T I E S
Non GMP Intermediate/ Fine Chemicals Manufacturing : Pilot Capacities : 5 Kgs to 50 Kgs
Glass Lined Reactors 300 to 500 lts
SS Reactors 600 lts
Nutsche Filters 30 to 50 Kgs
Centrifuges 36 “
Driers Tray driers, RCVD glass
lined
FA C I L I T I E S
Non GMP Intermediate/ Fine Chemicals Manufacturing. Large Scale Capacities : 50 Kgs to 500 Kgs
Glass Lined Reactors 1500 to 3000 lts
SS Reactors 1000 to 6000 lts
Nutsche Filters 100 to 400 Kgs
Centrifuges 36’ & 48”
Driers RCVD, Tray Driers
Hydrogenator 2000 lts 40 Kgs pressure
FAC I L I T I E S
Large Scale Manufacture of APIs under c GMP conditions: Capacity : 100 to 500 Kgs
Glass Lined Reactors
1500 lts
SS Reactors 2000 to 3000 lts
Centrifuges 48”
Driers Rotary Vacuum Driers, Fluid
bed driers
Particle Size modification equipments
Multi-mill, Compactor, Sifter
§ Manufacturing systems and Documentation complying to cGMP, ICH
Q7A guidelines
Regular Internal Audits
Stringent change control systems
Validation Master Plans :
Q UA L I T Y A S S U R A N C E & R EG U L ATO RY
Process Validation
Cleaning Validation
Equipment Qualification
Extensive Product Release Controls
Q UA L I T Y A S S U R A N C E & R EG U L ATO RY
Drug Master Files for APIs in CTD format
Stability Data Support
Analytical Method Validation
Process Validation
Q UA L I T Y C O N T R O L A N D A N A LY T I C A L S U P P O R T
Sophisticated Analytical Lab with:
› HPLCs, GCs , FTIR & UV Spectrometers, Autotitrators, LCMS, NMR...
› Validated and calibrated systems
› Methods Development, Standardisation and Validation
Analytical Development, Specification Development
• API / API Intermediate specifications complying to ICH
• CMC guidelines
Method Validation as per ICH guidelines
Qualified and Experienced Man power
SHE Programs:
Personal Safety
Process Safety
Environmental Safety
Risk Analysis
On Site Emergency Plan
Environmental Management Programme
S A F E T Y H E A LT H A N D E N V I R O N M E N T ( S H E )
Thank You………